Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Circulating-fluid localized thermal/compression therapy system control unit FDA UDI
- Device Name
- Quick fitting, universal, knee brace. Quick inflation system that's easy to use. FDA UDI
- Model / Reference
- ManaEZ Ice Compression Wrap Knee FDA UDI
- Description
- Quick fitting, universal, knee brace. Quick inflation system that's easy to use. FDA UDI
Identifiers
- Catalog Number
- EZCPWK01 FDA UDI
- Primary DI / UDI-DI
- 00810113682402 FDA UDI
- FDA Product Code
- IRP FDA UDIITQ FDA UDI
- GMDN Term
- Circulating-fluid localized thermal/compression therapy system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5650 FDA UDI890.3475 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ManaMed by Manamed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI 251b1440-0b12-40fe-9bc0-8f55338890e2 36 fields · synced May 30, 2026